2024-03-04 LIDR Meeting Notes

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M - Solventum

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Sandy Jones

CDC

Stan Huff

Graphite

Ed Heierman

Abbott / IICC

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

Marti Velezis

 Sonrisa / FDA

Walter Sujansky

FDA

Susan Downer

JMC

Ralf Herzog

Roche

Cornelia Felder

Roche

Daniel Golson

JMC

Andrea Prada

JMC

Maria Sagat

 CAP

Raja Cholan

FDA

Russ Ott

FDA

Akila Namasivayam

FDA

Desiree Mustaquim

CDC

Reviewing minutes from the last call - Action Item Follow up

• Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary

  • Review operational definition of “equivalence”

• Outreach to Dr. DeBaca

  • Hung will check for more info and maybe see, if she could participate in SHIELD

• Waiting for response from Ed

• Keep updating the googlesheet: Potassium LIVD data

• Shared Reportable Conditions LIVD google sheet for crowdsourcing with CSTE - added sign up sheet for PHAs to specific conditions and see how that develops

• Have LIVD File Repository Requirements

  Have draft budget (for setting up a web-based database and yearly maintenance): https://aphlinformatics.atlassian.net/wiki/download/attachments/915407143/LIDR - Budget.xlsx?api=v2

• Sign up for sections to provide draft content on the LIDR White Paper

• Review LIDR Use Cases and sign up to lead one of these

• Define next steps to migrate existing LIVD files into FHIR LIVD catalog format and find a FHIR server to host

Call Schedule

send OOO via chat or email

LIDR Elements Discussion

Continue with review of the PT and Haemtology example Hung created

Open

Take up these questions today:

• reference range differences - what is acceptable

• discuss approach about broad LOINC vs more specific LOINC

• Keep iStat separate - since POCT device

Discussion:

Looking at WBC

Abbott feedback on coding for their instruments - has instrument and reagent in the GUUID

different units of measure between both

Sysmex has some instrumentation in GUUID, but not this one, they specify 2 reagents kits, but one of these is for lysing the RBCs - so used the other one for testkit

for both use whole blood - picked venipuncture

Do we agree we need both reagents and instruments?

UDI is not required for all instruments that are FDA approved - the vendor has to request the UDI

There are 3 levels of devices the FDA that require UDI starting at a specific date. Clarify with FDA:

#1 what is the requirement for Lab instruments to have UDI

#2 what is the timeline for having UDI in GUUID

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system

For LDTs (test on un-approved specimen) would still use the same instrument and reagents for these

Mulitple reagents in the package insert? How do we decide which to include?

Ideally have the vendors define which reagents

do we require the instrument and the reagent, even if we know it makes no difference?

Policy should be to send ALL THE TIME - because that is for just one use case = harmonization, but if we want to support other use cases, like PH surveillance and regulatory surveillance

If for the latter, can we limit to just one reagent, for the regulatory use case? Separate recall situations from normal clinical use - becasue for reagent you would have to know the lot number, so may start with a

classifying a group of reagents with a single identifier - leavel off inventory and recall (lot number level)

Reason to have the reagent kit (or kit combination in this table is two-fold:
#1 identify the specific test the lab is setting up - help find which test I am using to select the LOINC (and other coding) is recommended

#2 and to indicate which should be sent

We AGREE we should have BOTH instrument, where applicable, AND reagent kit identifier (grouper) and ideally they should each be represented by the device identifier of the UDI in LIVD / LIDR

For lookup go by vendor -> instrument -> analyte ->reagent kit

for the future it would be good to use computable ways to identify the instrument, which the DI of the UDI - followed by GTIN - only if not any computable way then use text

Include examples of why testkit information is important in the white paper (albumin kit - green or purple)

DI UDI of instrument + DI UDI of reagent + LOINC should be unique

Need some clarification:

Why are we asking folks to do this?

Where would we send these in the HL7 messages, how would they be recorded in the LIS? and what will this data be used for?

#1 for better understanding if results from outside labs are trendable with internal results requires this level of knowledge unless these are part of the 200 harmonized lab tests

#2 support regulatory decision making in post-market surveillance

#3 suporting results from at home devices into patient’s chart in the EHR

Review LIDR White Paper

 not discussed

ACTION ITEMS

Please see the action items at top of this page - Next deliverable is White paper draft by end of this month

And we need to prioritize the use cases, so that we can finalize the requirements for the first phase of LIDR, which need to be included in the White paper

Next call

Monday 3/11/2024 9 - 10 AM ET

Adjourned

10:00 AM ET